Omron RS7 Intelli IT User manual

PM-1771-E-01-03/2018
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33 2132 LR Hoofddorp The Netherlands
P.O. Box 2050 2130 GL Hoofddorp The Netherlands
Phone: [phone] fax [phone]
www.omron.healthcare.com
BANKERS JP Morgan Chase Bank NA ACC. NR.
413.90.366
IBAN GB04CHAS60924241390366 SWIFT CHASGB2L
CHAMBER OF COMMERCE NR. 342.10306
BTW/VAT NR. NL8132.86.281.B01
New Product Information Sheet
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code):
RS7 Intelli IT (HEM-6232T-E)

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Product description: Automatic Wrist Blood Pressure Monitor
Product category: Electronic Sphygmomanometers
Model (code): RS7 Intelli IT (HEM-6232T-E)
LEGAL MANUFACTURER
OMRON HEALTHCARE Co., Ltd
53, Kunotsubo, Terado-cho, Muko, KYOTO,
617-0002 Japan
PRODUCION FACILITY
OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.
No.28 VSIP II, Street2, Vietnam-Singapore Industrial Park II,
Binh Duong Industry-Services Urban Complex, Hoa Phu Ward,
Thu Dau Mot City, Binh Duong Province, Vietnam
EU REPRESENTATIVE
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp,
THE NETHERLANDS

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Included accessories / optional accessories
n/a
General description
The RS7 Intelli IT is an automatic wrist blood pressure monitor, operating on the
oscillometric principle. This blood pressure monitor is to be worn on your wrist. When
the cuff inflates, this monitor senses the pressure pulsations of the artery underneath
the cuff.
Packaging content
The manufacturer produces the HEM-6232T-E with the applicable accessories
included, necessary for the application of its intended purpose.
1. Monitor
2. Storage case
3. 2 “AAA” alkaline batteries
4. Instruction Manual
5. Setup instructions
Purpose
This device is a digital monitor intended for use in measuring blood pressure and
pulse rate in adult patient population with wrist circumference ranging from 13.5 cm
to 21.5 cm.
Application field
This monitor detects the appearance of irregular heartbeats during measurement
and gives a warning signal with readings. It is mainly designed for general household
use.

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Intended user
• Legally certified medical experts, such as doctor, nurse and therapist, or
healthcare personnel or patient under the guidance of qualified medical
experts.
• The user should also be capable of understanding general operation of this
device and the content of instruction manual.
Indications for use
This device is a digital monitor intended for use in measuring blood pressure and
pulse rate in adult patient population.
Features (Particularities)
RS7 Intelli IT (HEM-6232T-E) is an automatic wrist type blood pressure monitor that
has the unique selling points as noted:
• Intellisense Technology
• OMRON connect mobile application for iPhone / AndroidTM
• Cuff wrapping guide
• Irregular heartbeat detection
• Pre-formed easy to fit cuff
• Stores up to 100 readings per user
• Average of 3 readings
Description of operating principle
How it works
This blood pressure monitor uses the oscillometric method of blood pressure
measurement. When the cuff inflates, this monitor senses the pressure pulsations of
the artery underneath the cuff. The pulses are called oscillometric pulses. The
electronic pressure sensor displays a digital reading of blood pressure.

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How to use the device
Main steps:
1. Wrap the wrist cuff correctly on a bare arm.
2. Sit correctly
3. Press start
4. Remain still until the measurement process is completed
5. Press the stop button to turn off
Review the Instruction Manual for the full details on the application of this product.
Technical data
Product category Electronic Sphygmomanometers
Product Description Automatic Wrist Blood Pressure Monitor
Model (code) RS7 Intelli IT (HEM-6232T-E)
Display LCD Digital Display
Cuff pressure range 0 to 299 mmHg
Blood pressure
measurement range
SYS: 60 to 260 mmHg
DIA: 40 to 215 mmHg
Pulse measurement range 40 to 180 beats / min.
Accuracy Pressure: ±3 mmHg
Pulse: ±5% of display reading
Inflation Automatic by electric pump
Deflation Automatic rapid deflation
Measurement method Oscillometric method
Transmission method Bluetooth® low energy technology
Wireless communication Frequency range: 2.4 GHz (2400 - 2483.5 MHz)
Modulation: GFSK
Effective radiated power: < 20 dBm
Operation mode Continuous operation
IP classification IP 22
Rating DC3 V 3.0 W
Power source 2 “AAA” alkaline batteries 1.5V
Battery life Approximately 300 measurements (using new alkaline batteries)
Durable period (Service life) 5 years
Operating conditions +10°C to +40°C / 15 to 90% RH (noncondensing) / 800 to 1060 hPa
Storage / Transport
conditions
-20°C to +60°C / 10 to 90% RH (noncondensing)

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Weight Approximately 91 g not including batteries
Dimensions Approximately 91 mm (w) × 63 mm (h) × 13 mm* (l)
(
not includin
g
the wrist cuff
)
Measurable wrist
circumference 13.5 to 21.5 cm
Memory Stores up to 100 readings per user
Contents Monitor, storage case, 2 “AAA” alkaline batteries, instruction manual, setup
instructions
Protection against electric
shock Internally powered ME equipment
Applied part Type BF (wrist cuff)
Maximum temperature of the
applied par
t
Lower than +48°C
EAN code 401567211117 2
* thinnest part
Note
• These specifications are subject to change without notice.
• In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood
pressure.
• This monitor is clinically investigated according to the requirements of ISO 81060-2:2013.
• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This
monitor is protected against solid foreign objects of 12.5 mm diameter and greater such as a finger,
and against oblique falling water drops which may cause issues during a normal operation.
• This device has not been validated for use on pregnant patients.

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Materials used in main device and all accessories
Parts Name Material
Front Housing Acrylonitrile butadiene styrene
Polymethyl methacrylate
Ground Housing Acrylonitrile butadiene styrene
Battery Cover Acrylonitrile butadiene styrene
Button Acrylonitrile butadiene styrene
Polymethyl methacrylate
LCD Glass
Robber key Silicone Rubber
Cloth Bag Polyester
Polyvinyl chloride
Air bag Polyvinyl chloride
Nipple Polyvinyl chloride
Ring Low Carbon Steel Wire Rods
Collar Polypropylene

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Title page of Instruction Manual

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Unfolded package design of main device and accessories
Main device:
Accessories:
n/a
Packaging specifications from Explanation Diagram
Package Amount Approx. weight Approx. dimensions
W x D x H, mm
Main Unit 1 90
g
91 x 13.4 x 63.4 mm
Packa
g
e 1 297
g
90 x 90 x 115 mm
Master Carton 10 3.2k
g
472 x 198 x 144 mm

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List of Harmonized EN Standards
The device is classified as a medical device, Class IIa (MDD Annex IX Rule 10)
Applicable Medical Device Directive (93/42/EEC) standards:
EN ISO 15223-1:2016
EN 1041:2008
EN 1060ꞏ1:1995+A2:2009
EN 1060ꞏ3:1997+A2:2009
EN 60601-1:2006+A1:2013
EN 60601-1-2:2015
EN 60601-1-6:2010+A1:2015
EN 60601-1-11:2015
EN 80601-2-30:2010+A1:2015
EN 62304:2006+A1:2015
EN 62366:2008+A1:2015
EN ISO 10993-1:20091AC:2010
EN ISO 10993-5:2009
EN ISO 10993-10:2013
EN ISO 14971:2012
EN ISO 81060-2:2014
Operation and care
Cleaning of the device
The device should be cleaned with a soft dry cloth, or a soft cloth moistened with
neutral soap to clean on the monitor and the wrist cuff.
Warnings
Please read the Important Safety Information in this instruction manual before using
this monitor.
Please follow this instruction manual thoroughly for your safety.
Please keep for future reference. For specific information about your own blood
pressure, CONSULT WITH YOUR PHYSICIAN.
Warning: Indicates a potentially hazardous situation which, if not avoided, could
result in serious injury.